SchizophreniaNCT02201888
Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
A study testing Computer-assisted cognitive training, Computerized active condition and Treatment as usual (TAU) in people with Schizophrenia, run by Salvador Sarró, MD at 1 site in Spain.
Trial summary
Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence suggests has consequences for functional adaptation and which cause difficulties in social re-integration after hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Computer-assisted cognitive training, Computerized active condition and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2010to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- schizophrenia or schizoaffective disorder fulfilling the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosis
- estimated premorbid intelligence quotient (IQ) in the normal range
- chronic illness (i.e. duration ≥two years)
- relative clinical stability (i.e. the patients had not experienced any recent exacerbation of symptoms).
Who cannot join
- history of brain trauma
- alcohol or substance abuse/dependence within the previous six months.
Trial locations and contacts
1 site in 1 country.
Spain1 site
FIDMAG Germanes Hospitalàries Research Foundation
Barcelona, Barcelona, 08035
About this study
Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence suggests has consequences for functional adaptation and which cause difficulties in social re-integration after hospitalization. The investigators propose a large scale, multicentric study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed at answering outstanding questions concerning the effectiveness of cognitive estimulation therapy for schizophrenic cognitive impairment. Specifically, the study will examine a) issues related to the size of the effect compared to treatment as usual and compared to a control intervention; b) generalizability of improvement to cognitive function and social cognition in daily life; and c) the durability of therapeutic gains after the end of treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three treatment conditions: a computer- assisted cognitive estimulation program (n=64), non-structured time on computer (n=64) and treatment as usual (n=64). A battery of neurocognitive tests of memory and executive function, including 'ecologically valid' measures, will be administered by blind evaluators at baseline, after 6 months of cognitive estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will be also be assessed at baseline, after the treatment and at follow-up.
- Conditions
- Schizophrenia
- Being tested
- Computer-assisted cognitive training, Computerized active condition, Treatment as usual (TAU)
- Keywords
- Schizophrenia, Rehabilitation, Cognition
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer-assisted cognitive trainingBehavioural
Also called Computer-assisted cognitive training (CRT)
Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
Computerized active conditionOther
Also called Computerized active condition (CC)
Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions.
TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities.
| Study group | Role | What they receive |
|---|---|---|
| Computer-assisted cognitive training | Experimental | Patients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention (4 minutes), attention/perception (5 minutes), working memory (8 minutes), auditory and visual memory (8 minutes), executive function (10 minutes), language (6 minutes), and games (4 minutes). Receives: Behavioral: Computer-assisted cognitive training |
| Computerized active condition | Active comparator | Patients allocated to this condition completed the same number of sessions as the cognitive training group but followed a computerized typing program (www.rapidtyping.com). This had similar design characteristics to the CRT condition, in that it was hierarchically organized with exercise level of difficulty being adjusted to the individual's level of performance and feedback being given at the end of each exercise. Additionally, patients in this condition played computerized games requiring typing (crosswords, word puzzles, etc) and were taught basic internet navigation by a supervisor. Exposure to the computer was of equivalent duration to the CRT condition. Receives: Other: Computerized active condition |
| Treatment as usual | Placebo comparator | Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Memory test battery
memory test battery Rivermead Behavioural Memory Test (RBMT)(Wilson, 1985) a memory test battery and the executive test battery, the Behavioural Assessment of the Dysexecutive Syndrome (BADS)(Wilson, 1996)
Measured: Six months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJan 2010
- Primary completionDec 2013
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 130 participants (actual)
Sponsor and investigators
- Lead sponsor
- Salvador Sarró, MD
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain
- Responsible party
- Sponsor-investigator, Salvador Sarró, MD, FIDMAG Germanes Hospitalàries
- Investigators
- Peter J McKenna, MD, Study director, FIDMAG Germanes Hospitalàries Research FoundationJesus J Gomar, PhD, Principal investigator, FIDMAG Germanes Hospitalàries Research FoundationEdith Pomarol-Clotet, MD, PhD, Study chair, FIDMAG Germanes Hospitalàries Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201888
- Sponsor's protocol ID
- PR-2009-15
- Other IDs
- PI09/90483
- Status last verified
- Jul 2014
- First submitted
- 24 Jul 2014
- Last updated
- 28 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Cognitive Rehabilitation Program: a Neurocognitive Study
- ClinicalTrials.gov ID
- NCT02201888
- Acronym / sponsor ID
- PR-2009-15
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Rehabilitation, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 130 participants (actual)
- Lead sponsor
- Salvador Sarró, MDUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Centro de Investigación Biomédica en Red de Salud Mental, Hermanas Hospitalarias del Sagrado Corazón de Jesús, Spain
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Schizophrenia is known to be associated with cognitive dysfunction which increasing evidence suggests has consequences for functional adaptation and which cause difficulties in social re-integration after hospitalization. The investigators propose a large scale, multicentric study (7 centres from the Hermanas Hospitalarias del Sagrado Corazón de Jesús network) aimed at answering outstanding questions concerning the effectiveness of cognitive estimulation therapy for schizophrenic cognitive impairment. Specifically, the study will examine a) issues related to the size of the effect compared to treatment as usual and compared to a control intervention; b) generalizability of improvement to cognitive function and social cognition in daily life; and c) the durability of therapeutic gains after the end of treatment. 192 patients with chronic schizophrenia will be randomly assigned to one of three treatment conditions: a computer- assisted cognitive estimulation program (n=64), non-structured time on computer (n=64) and treatment as usual (n=64). A battery of neurocognitive tests of memory and executive function, including 'ecologically valid' measures, will be administered by blind evaluators at baseline, after 6 months of cognitive estimulation, and after 6 months follow-up. Symptoms, social functioning and self-esteem will be also be assessed at baseline, after the treatment and at follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Computer-assisted cognitive training | Experimental | Behavioral: Computer-assisted cognitive trainingPatients in this arm of the trial carried out computerized online training drawn from the Feskits program (www.feskits.com), chosen to have attention, memory and executive function components. Specifically the sessions included the following exercises: sustained attention (4 minutes), attention/perception (5 minutes), working memory (8 minutes), auditory and visual memory (8 minutes), executive function (10 minutes), language (6 minutes), and games (4 minutes). |
| Computerized active condition | Active comparator | Other: Computerized active conditionPatients allocated to this condition completed the same number of sessions as the cognitive training group but followed a computerized typing program (www.rapidtyping.com). This had similar design characteristics to the CRT condition, in that it was hierarchically organized with exercise level of difficulty being adjusted to the individual's level of performance and feedback being given at the end of each exercise. Additionally, patients in this condition played computerized games requiring typing (crosswords, word puzzles, etc) and were taught basic internet navigation by a supervisor. Exposure to the computer was of equivalent duration to the CRT condition. |
| Treatment as usual | Placebo comparator | Other: Treatment as usual (TAU)Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- schizophrenia or schizoaffective disorder fulfilling the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria diagnosis
- estimated premorbid intelligence quotient (IQ) in the normal range
- chronic illness (i.e. duration ≥two years)
- relative clinical stability (i.e. the patients had not experienced any recent exacerbation of symptoms).
Key exclusion criteria (2 listed)
- history of brain trauma
- alcohol or substance abuse/dependence within the previous six months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computer-assisted cognitive trainingAlso: Computer-assisted cognitive training (CRT)Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions. | Behavioural | Computer-assisted cognitive training |
| Computerized active conditionAlso: Computerized active condition (CC)Treatment lasted six months. The CRT and CC conditions consisted of biweekly sessions of 45 minutes. Patients in both conditions trained in groups of up to 8, supervised by a single person. The CRT and CC groups were scheduled at different times. The same personnel supervised both treatment conditions. All supervisors were trained by the coordinator of the study in the technical management of the two conditions. | Other | Computerized active condition |
| Treatment as usual (TAU)TAU: Patients in this condition participated in their (individually variable) daily rehabilitative activities. Patients allocated to the other two conditions also participated in these activities. | Other | Treatment as usual |
Primary outcome
Memory test battery
Time frame: Six months
memory test battery Rivermead Behavioural Memory Test (RBMT)(Wilson, 1985) a memory test battery and the executive test battery, the Behavioural Assessment of the Dysexecutive Syndrome (BADS)(Wilson, 1996)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter J McKenna, MD study director
FIDMAG Germanes Hospitalàries Research Foundation
Jesus J Gomar, PhD principal investigator
FIDMAG Germanes Hospitalàries Research Foundation
Edith Pomarol-Clotet, MD, PhD study chair
FIDMAG Germanes Hospitalàries Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer-assisted cognitive training, Computerized active condition and Treatment as usual (TAU) in people with Schizophrenia, run by Salvador Sarró, MD at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Memory test battery (time frame: Six months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2014.